FDA recall D-1086-2023

ALEMBIC PHARMACEUTICALS, INC. · Class III · drug

Product

Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ 07921, USA, NDC 62332-518-05

Reason for recall

Failed Impurities/Degradation Specifications

Distribution

Nationwide in the USA

Key facts

Status
Ongoing
Initiation date
2023-07-27
Report date
2023-08-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bedminster, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1086-2023